FDA.reportPublic FDA data

Azelastine Hydrochloride and Fluticasone Propionate

Product NDC
0378-3458
11-digit product format
003783458
Labeler code
0378
Product ID
0378-3458_6e1e173a-2d01-4e67-8361-dd30604bc8aa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azelastine Hydrochloride and Fluticasone Propionate
Dosage form
SPRAY, METERED
Route
NASAL
Labeler
Mylan Pharmaceuticals Inc.
Application
NDA202236
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2020-04-14
Marketing end
2027-02-28
Substance
AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE
Active strength
137; 50 ug/1; ug/1
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Azelastine Hydrochloride and Fluticasone Propionate

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AZELASTINE HYDROCHLORIDE137 ug/1
FLUTICASONE PROPIONATE50 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0L591QR10I, O2GMZ0LF5W
Rxcui1797847

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f4fb2f5a-dadb-40e3-a4b1-a2a58f5d9a33Product name320260126
343e8617-eb68-1e10-cfa9-8c30af285764Product name320240513
a31ad3df-8021-2ea1-94eb-0fe2f49b7729Product name420220719
85ee67c3-6973-4172-9ada-b124d28b42f8Product name520210528
6397aa5d-11e2-42ce-b46f-ac49599ccf00Product name520201006
033d5d5b-187f-1f40-1e5a-11d732813f92Product name420200626
813fe018-3e3c-40e4-8f71-7ab50f3dfe81Product name220180723
3bcd721e-0555-4bc3-96c6-690471ff9d94Product name120171113
9f9452df-fa34-43d4-97fe-c6605344c5a8Product name120171113
0e5a25a6-9f05-44b5-8449-aa63e59f7202Product name120170426
f3c5232f-03de-44f5-996a-90cd9c08bc60Product name120170426
1cb17fbb-0da4-2841-37bc-e7079783e1a2Product name120140508
667f427a-8698-a508-767a-53ed61b4c2e9Product name120140508
6a97ffc8-1d4d-a971-4978-85ba3a22eac9Product name120140508
6df84e13-2223-fa46-1e26-17e2f58a1e1cProduct name120140508
90fec588-984c-4375-cfd4-7e40114bdf80Product name120140508
9c1d3c48-b162-204b-f55b-e0f25c31c52eProduct name120140508
9fdb6139-394b-1510-4baf-bde68c419789Product name120140508
aef26912-037b-9a4e-db49-225ef6dfd8f1Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0378-3458-23Azelastine Hydrochloride and Fluticasone Propionate1 in 1 BOXSPRAY, METERED18
0378-3458-23Azelastine Hydrochloride and Fluticasone Propionate120 in 1 BOTTLESPRAY, METERED1208

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-3458-23GM - Gram0378-3458ab20276f-246a-41c8-a84d-b23cab5f71a812020-05-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-3458AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE SPRAY, METERED [MYLAN PHARMACEUTICALS INC.]7Current NDC, Legacy NDC, 2 package rows20250210_7b5cc5a0-0d47-46b5-b5fb-eb9cc248ae9e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1797847azelastine HCl 137 MCG/ACTUAT / fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SprayPSN7b5cc5a0-0d47-46b5-b5fb-eb9cc248ae9e8
1797847azelastine hydrochloride 0.137 MG/ACTUAT / fluticasone propionate 0.05 MG/ACTUAT Metered Dose Nasal SpraySCD7b5cc5a0-0d47-46b5-b5fb-eb9cc248ae9e8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0378-3458-23003783458231 BOTTLE in 1 BOX (0378-3458-23) / 120 SPRAY, METERED in 1 BOTTLE1 bottle2020-04-142027-02-28NoNoCurrent